Conducting a randomized control trial of oxygen in children with Down syndrome to treat moderate to severe obstructive sleep apnea.

The aim of the study is to conduct a comparison between the 2 methods of oxygen delivery during sleep in 15 children from Cincinnati Children's Hospital and Children's Hospital of Los Angeles. 2 polysomnographies will be performed, one with continuous flow and the second with pulse flow.

Cincinnati Children's Hospital received NIH funding to conduct a randomized control trial of oxygen in children with Down syndrome to treat moderate to severe obstructive sleep apnea. Oxygen may be delivered through continuous flow for the duration of the respiratory cycle or pulse flow during inspiration only. Pulse flow oxygen concentrators have been used clinically in adults. However, there is limited experience with this technology in children. The advantages of pulse flow oxygen concentrator are its portability and its ability in providing compliance data.

This is a pilot research study to compare the 2 methods of oxygen delivery during sleep in 15 children from Cincinnati Children's Hospital and Children's Hospital of Los Angeles. 2 polysomnographies will be performed, one with continuous flow and the second with pulse flow. The pilot study is conducted in preparation for a larger project which will include 7 sites aiming at determining the effect of oxygen treatment on the frequency of obstructive apnea, neurocognitive and cardiac outcomes. A separate Institutional Review Board (IRB) protocol of the larger study will be submitted later once approved by the NIH Data and Safety Monitoring Board.

Inclusion Criteria:

1. Age 5-17 years with or without Down Syndrome (DS).
2. Children with obstructive sleep apnea (OSA) and obstructive apnea hypopnea index (OAHI) 5-40 / hour: The rationale for selecting this range of OAHI is that a large number of children with DS with this range of OSA severity are untreated for months to years. It is important to understand the response to oxygen across the spectrum of disease severity. Notably, children with severe disease are left with few options (e.g., tracheostomy).
3. Absence of clinically significant hypoxia defined as oxygen saturation < 88% for 5 minutes or episodic desaturation to 60% as these levels would otherwise identify children eligible to routinely receive oxygen.

Exclusion Criteria:

1. Current CPAP use with documented compliance (> 4 hrs/ night; > 70% of nights).
2. Oxygen saturation < 90% at rest during wakefulness
3. Chronic daytime or nighttime use of supplemental oxygen.
4. Unable to participate in a Polysomnogram (PSG).
5. Enrolled or planning to enroll in another study that may conflict with protocol requirements or confound results in this trial.

The primary goal of this study is to assess feasibility of using pulse oxygen flow in children with Down syndrome and obstructive sleep apnea population. Preliminary data on the response rates from the two concentrators will be obtained and a confidence interval for the difference in response rate will be obtained. Data that is obtained from the devices will be shared with Inogen. Data will be deidentified prior to sending.

1 year

Pending